Alimera Sciences, Inc.
) suffered a setback when it received a Complete Response Letter
(CRL) from the U.S. Food and Drug Administration (FDA) for its
New Drug Application (NDA) for Iluvien. Alimera's share price was
down 8.5% following the news.
Alimera is looking to get Iluvien approved in the U.S. for the
treatment of pseudophakic patients suffering from chronic
diabetic macular edema (DME) considered insufficiently responsive
to available therapies for the disease.
The U.S. regulatory body stated in its CRL that it cannot approve
the NDA for Iluvien in its present form after identifying some
concerns regarding the benefit-to-risk and safety profile of the
candidate. The FDA also asked for additional clinical study
results to support Iluvien's approval.
In addition, the FDA noted some a shortcomings regarding
Iluvien's manufacturing facility. However, Alimera believes that
this will not affect its European commercial supply of Iluvien.
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The regulatory body also suggested that Alimera should conduct a
meeting with the Dermatologic and Ophthalmic Drugs Advisory
Committee for further details on this issue. As per Alimera, an
Advisory Committee meeting would be held on Jan 27, 2014.
We remind investors that the approval path for Iluvien has been
at best rocky in the U.S. This is the third CRL that the company
received from the regulatory body. In the first quarter of 2013,
Alimera resubmitted an NDA for Iluvien in response to the second
CRL received in Nov 2011 from the FDA. The first CRL was received
in Dec 2010.
Although the company stated in its press release that it intends
to work with the FDA regarding the approval of Iluvien, we remain
extremely doubtful of the U.S. approval of the candidate after
the receipt of the third CRL.
We note that Alimera had collaborated with pSivida Corp. (PSDV)
to develop Iluvien for DME. The association between the two
companies dates back to Feb 2005. Iluvien is already approved in
the UK, Austria, France, Germany, Portugal and Spain, while in
Italy it has been recommended for approval for the treatment of
vision impairment associated with chronic DME for patients
considered insufficiently responsive to available therapies.
Alimera carries a Zacks Rank #3 (Hold). Stocks such as
AMAG Pharmaceuticals, Inc.
Isis Pharmaceuticals, Inc.
) currently look better positioned in the pharma space with a
Zacks Rank #1 (Strong Buy).